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Update of FDA’s Treatment of Acetaminophen

Beginning yesterday, the FDA gathered more than 35 experts in Maryland to discuss their options of how to prevent overdoses of over-the-counter acetaminophen. Acetaminophen is the pain and fever reducing active ingredient in drugs such as Tylenol and Excedrin. Acetaminophen overdose is the leading cause of liver failure in the United States. We reported in May that the FDA was going to require acetaminophen to have stronger labels. The two day meeting that the FDA began yesterday was to discuss all of the alternatives in order to cut back on overdoses, including stronger warnings or pulling products from the shelve all together.

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose. The FDA says patients often pair them with a pure acetaminophen medication, like Tylenol, exposing themselves to unsafe levels of the drug. Manufacturers of the drugs argue that the FDA is overemphasizing the dangers of acetaminophen. Only 10% of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association. The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.’s Percocet, which combines oxycodone and acetaminophen.

Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80% of the market comprised of over-the-counter products. Manufacturers of the drugs also warned panelists that any new restrictions on acetaminophen would force patients to switch to nonsteroidal anti-inflammatory drugs (NSAIDS), which carry risks of gastrointestinal bleeding and sometimes fatal kidney injury. In response, the FDA has stated that its intent is only to reduce liver injury, not to decrease acetaminophen use or encourage the use of NSAIDS.

For more information, see the St. Louis Post-Dispatch article at:
http://www.stltoday.com/stltoday/news/stories.nsf/sciencemedicine/story/4CDAC39AECC98D31862575E50017457A?OpenDocument

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